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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-475-20
Device Problems Unintended Movement (3026); Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/20/2022
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the pipeline was unable to be resheathed and did not open.The patient was undergoing treatment for an unruptured aneurysm located in the right paraclinoid ica aneurysm, which was noted to be off-label.The patient's vessel tortuosity was normal.It was reported that there was a resheathing issue with the pipeline.The tip of the pipeline braid was stuck between the microcatheter and was not opening up.The doctor flipped the ptfe sleeves and at first the braid opened pretty well, but when they tried to drag and drop and again open it after resheathing, the braid was stuck and was not able to advance.It was noted that there was severe friction/difficulty during delivery/positioning, and movement during deployment.The pipeline did not miss the landing zone, and did not jump during deployment.The pipeline was placed at least 3mm past the aneurysm neck on each side.The side branches were not covered by the pipeline, and the tip of the catheter had moved during deployment.The pipeline was replaced, which was implanted at the intended location. the patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).Ancillary devices include an 8f rightfemoral sheath, phenom plus guide catheter, phenom 27 microcatheter, and synchro 2 guidewire.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported the pipeline shield was unable to be resheathed as the distal aspect of the pipeline shield was stuck in proximal aspect of the phenom 27 150cm.The distal aspect of the pipeline stent remained inside the proximal aspect of the phenom 27.After the ¿majority¿ of the pipeline shield was resheathed into the sleeve, the physician was unable to insert a synchro-2 wire into the phenom 27 as it was plugged at the proximal aspect of the microcatheter.The rhv/tuohy-borst attached to the phenom 27 was not blocked.There was no issue with the pipeline opening.The pipeline initial opening was in the right m1 and we dragged back into the right internal carotid artery (ica) terminus.This was for a right paraclinoid ica aneurysm.While pushing the device out across the aneurysm neck, the distal aspect of the pipeline had fallen into the aneurysm neck region.Did plan to reuse this pipeline but the resheathing process was dysfunctional as described above.Therefore this pipeline was discarded.Used a replacement pipeline with distal placement in the proximal right m1 and it deployed perfectly.
 
Manufacturer Narrative
H3: product analysis # (b)(6):¿ equipment used: vis (m-85519), 203cm ruler (m-83360) ¿ drawing(s) referenced: none ¿ as found condition: the pipeline flex pusher was returned for analysis within a primary shipping box, within a secondary shipping box, within a plastic pouch, and within a plastic bio-pouch.¿ damage location details: no bends or kinks were found with the pipeline flex pusher.The pipeline flex pusher distal hypotube was found stretched with the shrink tubing pulled back from the proximal bumper.The pipeline flex pusher proximal bumper and resheathing pad were found in good condition.The pipeline flex pusher distal core wire was found broken at ~5.8cm from the proximal bumper.The pipeline flex pusher sleeves and tip coil and the pipeline flex braid were not returned.¿ testing/analysis: the broken pipeline flex distal core wire was sent out for sem (scanning electron micrographic) failure analysis.Per the analysis report, the wire failed via torsional overload.¿ conclusion: based on the device analysis and reported information, the customer¿s ¿failure/incomplete to open¿ report could not be confirmed.The pipeline flex braid was not returned.Possible causes of ¿failure/incomplete open¿ include patient vessel tortuosity, damaged braid, or user deploys braid in vessel bend.The patient¿s vessel tortuosity was ¿normal¿, ruling out patient vessel tortuosity as a potential cause.The pipeline flex braid was not returned; therefore, an analysis could not be performed, and braid damage could not be ruled out as a potential cause.Information regarding placement of the braid was not reported; therefore, user deploys braid in vessel bend could not be ruled out as a potential cause.Regarding the customer¿s ¿resistance during re-sheathing/failure to resheath¿ report, the issue could not be confirmed.Possible causes of ¿resistance during re-sheathing/failure to resheath¿ include patient vessel tortuosity, catheter damage, or user does not maintain continuous flush.The patient¿s vessel tortuosity was ¿normal¿, ruling out patient vessel tortuosity as a potential cause.The phenom 27 catheter was not returned; therefore, an analysis could not be performed, and catheter damage could not be ruled out as a potential cause.Information regarding use of a continuous flush was not reported; therefore, user does not maintain continuous flush could not be ruled out as a potential cause.Regarding the customer¿s ¿resistance/stuck during delivery¿ report the issue was confirmed.Damage to the pipeline flex pusher (stretching/separation) can occur if the device is advanced/retrieved against resistance.Possible causes of ¿resistance/stuck during delivery¿ include use of an incompatible catheter, catheter damage, patient vessel tortuosity, or user does not maintain continuous flush.The phenom 27 catheter was not returned; therefore, an analysis could not be performed, and catheter damage could not be ruled out as a potential cause.However, the phenom 27 catheter is compatible with the pipeline flex embolization device.The patient¿s vessel tortuosity was ¿normal¿, ruling out patient vessel tortuosity as a potential cause.Information regarding use of a continuous flush was not reported; therefore, user does not maintain continuous flush could not be ruled out as a potential cause.(rosaj10 2023-03-27) medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
PIPELINE FLEX W/SHIELD TECHNOLOGY
Type of Device
INTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key14830795
MDR Text Key295065116
Report Number2029214-2022-01065
Device Sequence Number1
Product Code OUT
UDI-Device Identifier00763000284633
UDI-Public00763000284633
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P100018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 03/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/05/2023
Device Model NumberPED2-475-20
Device Catalogue NumberPED2-475-20
Device Lot NumberB113087
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/05/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age65 YR
Patient SexFemale
Patient Weight80 KG
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